Phase I Study of Cell Therapies for the Treatment of Patients With Relapsed or Refractory AML or High-risk MDS

Inclusion criteria

• . 18 years or older
• . For AML Subjects: WHO-confirmed AML, other than APL, with no standard treatment options available (WHO AML Criteria 2016)
• . Failure on at least 1 cycle of an anthracycline-based induction therapy
• . At least 1 cycle of high or intermediate dose cytarabine containing induction regimen
• . At least 2 cycles of VEN-based lower intensity therapy, e.g., with HMA, or LDAC or cladribine+LDAC
• . At least 4 cycles of HMA-based therapy without venetoclax
• .For MDS Subjects: A diagnosis of MDS and ≥10% bone marrow blasts with indication of high-risk disease defined as those having resistant or refractory disease to at least one course of therapy including hypomethylating agents (e.g., decitabine or 5-azacitidine) given at conventional dose, schedule, and duration (e.g., cycle every 28 days and for at least 4 cycles) with or without venetoclax or other agents. Failure is defined as failure to attain a response, or relapse after prior response to HMA therapy per the modified IWG criteria.
• . Creatinine clearance ≥50 ml/min (Cockcroft-Gault or 24-hour urine collection in cases in which Cockroft-Gault is unreliable or if preferred by physician) and not on dialysis

Exclusion criteria